The following data is part of a premarket notification filed by Brainsway Ltd. with the FDA for Brainsway Deep (dtms) System.
| Device ID | K203616 |
| 510k Number | K203616 |
| Device Name: | Brainsway Deep (DTMS) System |
| Classification | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
| Applicant | Brainsway Ltd. 19 Hartom Str. Jerusalem, IL 9777518 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A. Stein Regulatory Affairs Consulting Ltd. 18 Hataas St., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | QCI |
| CFR Regulation Number | 882.5802 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-04-16 |